This subpart establishes processes for review of RCE or ASTP/ONC actions, including QHIN appeal rights and the process for filing an appeal.

(a) ASTP/ONC may, in its sole discretion, review all or any part of any RCE determination, policy, or action. If ASTP/ONC reviews an RCE determination that required ASTP/ONC's prior authorization under this part, no ASTP/ONC officer, employee, or agent who was engaged with helping to evaluate or decide the prior authorization, or a prior authorization involving the same party(s) or underlying facts, may participate in deciding or advising ASTP/ONC on its review of that determination.

(b) ASTP/ONC may, in its sole discretion and on notice to affected QHINs or Applicant QHINs, stay any RCE determination, policy, or other action pending ASTP/ONC review. If ASTP/ONC stays an RCE determination that required ASTP/ONC's prior authorization under this part, no ASTP/ONC officer, employee, or agent who was engaged with helping to evaluate or decide the prior authorization, or a prior authorization involving the same party(s) or underlying facts, may participate in deciding or advising ASTP/ONC on whether it should stay that determination.

(c) ASTP/ONC may, in its sole discretion and on written notice, request that a QHIN, Applicant QHIN, or the RCE provide ASTP/ONC additional information regarding any RCE determination, policy, or other action.

(d) On completion of its review, ASTP/ONC may affirm, modify, or reverse the determination, policy, or other action under review. ASTP/ONC will provide notice to affected QHINs or Applicant QHINs that includes the basis for ASTP/ONC's decision.

(e) ASTP/ONC will provide written notice under this section to affected QHINs or Applicant QHINs in the same manner as the original RCE determination, policy, or other action under review.

(f) ASTP/ONC will issue a decision under this section within a timeframe agreed to by the affected Applicant QHIN or QHIN, as applicable, the RCE, and ASTP/ONC. ASTP/ONC may, at its sole discretion, extend the timeframe for a decision as circumstances necessitate.

(a) An Applicant QHIN or QHIN may appeal the following decisions to ASTP/ONC or a hearing officer, as appropriate:

(1) Applicant QHIN. An Applicant QHIN may appeal a denial of its QHIN application.

(2) QHIN. A QHIN may appeal:

(i) A decision to suspend the QHIN or to instruct the QHIN to suspend its Participant or Subparticipant.

(ii) A decision to terminate the QHIN's Common Agreement.

(b) [Reserved]

(a) To initiate an appeal, an authorized representative of the Applicant QHIN or QHIN must submit electronically, in writing to ASTP/ONC, a notice of appeal that includes the date of the notice of appeal, the date of the decision being appealed, the Applicant QHIN or QHIN that is appealing, and the decision being appealed within fifteen (15) calendar days of the Applicant QHIN's or QHIN's receipt of the notice of:

(1) Denial of a QHIN application;

(2) Suspension or instruction to suspend its Participant or Subparticipant; or

(3) Termination. With regard to an appeal of a termination, the 15-calendar day timeframe may be extended by ASTP/ONC up to another fifteen (15) calendar days if the QHIN has been granted an extension for completing its remedy under § 172.502(a).

(b) An authorized representative of an Applicant QHIN or QHIN must submit electronically to ASTP/ONC, within thirty (30) calendar days of filing the intent to appeal, the following:

(1) A statement of the basis for appeal, including a description of the facts supporting the appeal with citations to documentation submitted by the QHIN or Applicant QHIN; and

(2) Any documentation the QHIN would like considered during the appeal.

(c) The Applicant QHIN or QHIN filing the appeal may not submit on appeal any evidence that it did not submit prior to the appeal except evidence permitted by the hearing officer under § 172.606.

An appeal does not stay the suspension or termination, unless otherwise ordered by ASTP/ONC or the hearing officer assigned under § 172.605(b).

(a) On receipt of an appeal under § 172.603, ASTP/ONC may exercise its authority under § 172.601 to review an RCE determination being appealed. If ASTP/ONC exercises its authority under § 172.601 to review an RCE determination that required ONC's prior authorization under this part, no ASTP/ONC officer, employee, or agent who was engaged with helping to evaluate or decide the prior authorization, or a prior authorization involving the same party(s) or underlying facts, may participate in deciding or advising ASTP/ONC on its review of that determination. An appealing QHIN or Applicant QHIN that is not satisfied with ASTP/ONC's subsequent determination may appeal that determination to a hearing officer by filing a new notice of appeal and other appeal documents that comply with § 172.603.

(b) If ASTP/ONC declines review under paragraph (a) of this section, or if ASTP/ONC made the determination under review, ASTP/ONC will arrange for assignment of the case to a hearing officer to adjudicate the appeal.

(c) The hearing officer must be an officer appointed by the Secretary of Health and Human Services.

(d) The hearing officer may not be responsible to, or subject to the supervision or direction of, personnel engaged in the performance of investigative or prosecutorial functions for ASTP/ONC, nor may any officer, employee, or agent of ASTP/ONC engaged in investigative or prosecutorial functions in connection with any adjudication, in that adjudication or one that is factually related, participate or advise in the decision of the hearing officer, except as a counsel to ASTP/ONC or as a witness.

(a) The hearing officer will decide issues of law and fact de novo and will apply a preponderance of the evidence standard when deciding appeals.

(b) In making a determination, the hearing officer may consider:

(1) The written record, which includes:

(i) The RCE's or ASTP/ONC's determination and supporting information; and

(ii) Appeal materials submitted by the Applicant QHIN or QHIN under § 172.603.

(2) Any information from a hearing conducted in-person, via telephone, or otherwise. The hearing officer has sole discretion to conduct a hearing:

(i) To require either party to clarify the written record under paragraph (b)(1) of this section; or

(ii) If the hearing officer otherwise determines a hearing is necessary.

(c) The hearing officer will neither receive witness testimony nor accept any new information beyond what was provided in accordance with paragraph (b) of this section, except for good cause shown by the party seeking to submit new information.

(a) The hearing officer will issue a written determination within a timeframe agreed to by the affected Applicant QHIN or QHIN, as applicable, and ASTP/ONC and approved by the hearing officer. The hearing officer may, at their sole discretion, extend the timeframe for a written determination as circumstances necessitate.

(b) The hearing officer's determination on appeal is the final decision of HHS unless within ten (10) business days, the Secretary, in the Secretary's sole discretion, chooses to review the determination. ASTP/ONC will notify the appealing party if the Secretary chooses to review the determination and will provide notice of the Secretary's final determination.